Covidien, formerly Tyco Healthcare, is $10 billion global
healthcare products company with market leading brands.
After our break
from Tyco, Nellcor Puritan Bennett is now the Respiratory and Monitoring
Solutions (RMS) business unit of Covidien. We are currently in process of
relocating our corporate headquarter from
SOFTWARE QUALITY ENGINEERING MANAGER –
Relocation Package available
Position Summary:
Oversee and manage Software Quality Assurance Engineers
ensuring that software used in the development, manufacturing, and as part of
medical devices is developed according to good design practices and follows the
corresponding requirements set forth by local procedures, regulatory
authorities and notified bodies. (e.g. FDA and TUV).
Minimum Requirements:
Bachelor of Science degree in
Electrical Engineering, Computer Science, or Computer Engineering
6+ years experience in
software test or software quality engineering with embedded software as part of
a medical device
Experience in a management
role
Working knowledge of and
auditing experience to the FDA Quality System Regulation, ISO 13485, and the
Medical Device Directive
Skilled in product risk
assessment (ISO 14971), requirements management and tracing, defect tracking,
configuration management techniques, and how they are applied in the software
development lifecycle
Understanding of current
Software Quality techniques, software industry standards (e.g. ISO, IEEE,
CMMI), and FDA Quality System Regulations and their impact on internal
procedures, software quality, safety and efficacy of products
Working knowledge of C, C++
CSQE Certification
SR. SOFTWARE QUALITY ENGINEER
- 1 position
Boulder, CO & 1 position Carlsbad, CA
Relocation package available
Position Summary:
Responsible for ensuring that software used in the
development, manufacturing and as part of medical devices is developed
according to good design practices and follows the corresponding requirements
set forth by local procedures, regulatory authorities and notified bodies. Provide leadership, oversight and training to
division manufacturing plants for computerized system validation.
Minimum
Requirements:
Bachelor of
Science degree in Electrical Engineering, Computer Science, or Computer
Engineering
5+ years in software quality
engineering role dealing with embedded software that is part of a medical
device.
Working knowledge of the FDA
Quality System Regulation, ISO 13485, and the Medical Device Directive
Skilled in product risk assessment
(ISO 14971), requirements management and tracing, defect tracking,
configuration management techniques, and how they are applied in the software
development lifecycle
Understand current Software
Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA
Quality System Regulations and their impact on internal procedures, software
quality, safety and efficacy of products
Working knowledge of C, C++,
and LabVIEW
If
you have a candidate you would like to submit, please email to Deborah.Cason@Covidien.com
By
submitting your candidate you will agree to the following terms:
Contingency
fee of 30%, paid on first annual years gross salary exclusive of any variable
compensation to include any type of bonus, stock, benefit, etc.
Payment
terms net 30 days, replacement guarantee 90 days.
NOTE: WE WILL ALSO CONSIDER CONSULTANTS
Covidien is an Affirmative Action / Equal Opportunity
Employer. We require vendors to not
discriminate on the basis of race, gender, national origin, age, disability,
marital status or any other protected trait or characteristic in any state in
which Covidien operates. Further, we
encourage diverse referrals.